Pharmaceutical company Acer Therapeutics has partnered with the National Center for Advancing Translational Sciences (NCATS) to develop emetine hydrochloride for the potential treatment of Covid-19 patients.
Under the research collaboration agreement, the partners will work together to speed-up the clinical development of emetine, which showed broad and potent antiviral activity in preclinical and clinical studies.
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Currently, Acer Therapeutics is in discussions with the US Food and Drug Administration (FDA)’s Division of Antivirals (DAV) following initial responses to its pre-investigational new drug (pre-IND) filing.
The company aims to file an IND in the middle of this year, with clinical trial commencement scheduled for the year’s third quarter, contingent on additional capital.
Acer proposed a randomised, blinded, placebo-controlled, multi-centre Phase II/II trial with an adaptive design to assess the safety and antiviral activity of emetine in high-risk, symptomatic, adult Covid-19 patients who do not need hospitalisation.
The objectives of the trial are the safety and efficacy of emetine determined using clinical status at a certain time point along with disease resolution.
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By GlobalDataMeanwhile, the company is exploring different financing options, including federally-funded research and grants, for the drug’s development.
Acer Therapeutics CEO and founder Chris Schelling said: “We are very pleased to be selected by NCATS and look forward to collaborating on the development of emetine, a broad-acting and potent antiviral identified by NCATS as their best preclinical opportunity for further clinical development for the treatment of Covid-19.
“With a collaboration agreement in place, ongoing discussions with the FDA toward IND submission, and several potentially non-dilutive funding sources being pursued, we believe we are well-positioned to advance the clinical development of emetine.”
Emetine will be administered as a sterile subcutaneous injection. The company will supervise the contract synthesis and manufacturing of the drug for clinical development and potential commercialisation.
